MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC. HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70M-JP-NA
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during servicing, the shutdown alarm "hardly sounded" on this ht70 ventilator.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.Section h9 fda correction number: 2024500-05-13-2025-001-r h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during servicing, the shutdown alarm "hardly sounded" on this ht70 ventilator.It was informed that third-party service provider tokibo (tkb) had evaluated the unit and replaced the control board.The unit was informed to be in working condition.Video provided identified that the device was power cycled off followed by a short shut down alarm beep.The cause of the issue could be due to either the system not being completely charged or an issue with c159 on the control board.The control board was received for analysis but was visually inspected and functionally tested with no malfunction or product deficiency observed.The cause of the reported event was identified as a potential fault of the c159 on the control board (c159), which could result in the shutdown alarm failing to annunciate.The ventilator is in the scope of a field corrective action (fca).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22172550
• Report Number: 2023050-2025-00028
• Device Sequence Number: 15757674
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1915-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown